Several thousand people have added their names to the sign-on letter at http://www.malecare.com, in just the first week. With May 31 as our dead line, many more names will be added. Our prostate cancer community is showing its size and cohesion. As Lance Armstrong so brilliantly advocates, we are living strong. We've also received about 45 emails of extraordinary passion. So, you all have given us an idea. Please consider writing an email about your experience with prostate cancer and your desire for a cure. A few sentences or paragraphs...write with facts or just from your heart....your choice. In fact, if you disagree with the sign-on letter on the malecare.com website, please write about that as well. We will include all of your emails in our presentation to the FDA, along with the thousands of your signatures. If we have time, we'll try to create an easy to read presentation rather than just hand in a stack of emails. Let's show the face of prostate cancer from our grass roots level. In many ways, the FDA is doing brilliant and life saving regulation and we are not at all out to do general bashing of their work. But, they have yet to see the large face of us. They need to know we are alive, but, not complaisant. We want carefully vetted treatments, but we want them before we or our loved ones die.

Rarely were the statistical flaws/ endemic biases in Nissen's methodology mentioned in press accounts:
1. Restriction of coverage issue: Nissen's trial selections were not free of bias--trials of Avandia in which patients had no adverse cardiovascular events in either group were excluded from analyses;
2. The pooled results were culled from a group of trials that were not originally powered to detect cardiovascular outcomes;
3. It has been observed that the conclusions of a meta-view can be shown to be different from a subsequent, larger, randomized clinical trial. Nissen's observed results were based on a relatively small number of events (86 myocardial infarctions in the rosiglitazone group and 72 in the control group); and,
4. Fallibility of broad applicability for Nissen's observed conclusions. Nissen said--and the press ran with his one comment--that rosiglitazone was associated with an increase in the risk(s) of cardiovascular morbidity and mortality.
….As the precise mechanisms underlying the actions of thiazolidinediones (TZDs) are largely unknown, it is a quantum leap to say that one drug in the class is safer than the other.